GENGRAF- cyclosporine solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

متاح من:

AbbVie Inc.

INN (الاسم الدولي):

CYCLOSPORINE

تركيب:

CYCLOSPORINE 100 mg in 1 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Gengraf® Oral Solution (cyclosporine oral solution, USP [MODIFIED ]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine (MODIFIED ) has been used in combination with azathioprine and corticosteroids. Gengraf® Oral Solution (cyclosporine oral solution, USP [MODIFIED ]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Gengraf® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Gengraf® Oral Solution (cyclosporine oral solution, USP [MODIFIED ]) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or can

ملخص المنتج:

Gengraf ® Oral Solution (cyclosporine oral solution, USP [MODIFIED]) A clear, colorless to yellow liquid supplied in 50 mL bottles containing 100 mg/mL with dispensing syringe (NDC 0074-7269-50). In the original container at controlled room temperature 68°-77°F (20°-25°C). (See USP Controlled Room Temperature). Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment may also occur. There is no impact on product performance or dosing using the syringe provided. Allow to warm to room temperature 77°F (25°C) to reverse these changes. Sandimmune® is a registered trademark of Novartis Pharmaceuticals Corporation. © AbbVie Inc. 2000-2021  AbbVie Inc., North Chicago, IL 60064, U.S.A. 20067180 February, 2021 

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

GENGRAF- CYCLOSPORINE SOLUTION
ABBVIE INC.
----------
GENGRAF ORAL SOLUTION
(CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED])
WARNING
ONLY PHYSICIANS EXPERIENCED IN MANAGEMENT OF SYSTEMIC
IMMUNOSUPPRESSIVE THERAPY FOR THE INDICATED DISEASE SHOULD PRESCRIBE
GENGRAF ORAL SOLUTION (CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED]). AT
DOSES USED IN SOLID ORGAN TRANSPLANTATION, ONLY PHYSICIANS EXPERIENCED
IN
IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF ORGAN TRANSPLANT
RECIPIENTS SHOULD PRESCRIBE GENGRAF
. PATIENTS RECEIVING THE DRUG SHOULD
BE MANAGED IN FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY
AND SUPPORTIVE MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR
MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE
FOLLOW-UP OF THE PATIENT.
GENGRAF
, A SYSTEMIC IMMUNOSUPPRESSANT, MAY INCREASE THE
SUSCEPTIBILITY TO INFECTION AND THE DEVELOPMENT OF NEOPLASIA. IN
KIDNEY,
LIVER, AND HEART TRANSPLANT PATIENTS GENGRAF MAY BE ADMINISTERED WITH
OTHER IMMUNOSUPPRESSIVE AGENTS. INCREASED SUSCEPTIBILITY TO INFECTION
AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA AND OTHER NEOPLASMS MAY
RESULT FROM THE INCREASE IN THE DEGREE OF IMMUNOSUPPRESSION IN
TRANSPLANT PATIENTS.
GENGRAF ORAL SOLUTION (CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED]) HAS
INCREASED BIOAVAILABILITY IN COMPARISON TO SANDIMMUNE ORAL SOLUTION
(CYCLOSPORINE ORAL SOLUTION, USP). GENGRAF AND SANDIMMUNE ARE NOT
BIOEQUIVALENT AND CANNOT BE USED INTERCHANGEABLY WITHOUT PHYSICIAN
SUPERVISION. FOR A GIVEN TROUGH CONCENTRATION, CYCLOSPORINE EXPOSURE
WILL BE GREATER WITH GENGRAF THAN WITH SANDIMMUNE . IF A PATIENT WHO
IS RECEIVING EXCEPTIONALLY HIGH DOSES OF SANDIMMUNE IS CONVERTED TO
GENGRAF
, PARTICULAR CAUTION SHOULD BE EXERCISED. CYCLOSPORINE BLOOD
CONCENTRATIONS SHOULD BE MONITORED IN TRANSPLANT AND RHEUMATOID
ARTHRITIS PATIENTS TAKING GENGRAF TO AVOID TOXICITY DUE TO HIGH
CONCENTRATIONS. DOSE ADJUSTMENTS SHOULD BE MADE IN TRANSPLANT PATIENTS
TO MINIMIZE POSSIBLE ORGAN REJECTION DUE TO LOW CONCENTRATIONS.
COMPARISON OF BLOOD CONCENTRATIONS IN THE PUBLISHED LITE